FDA Orange Book

Generic for IV Persantine

IV Persantine contains dipyridamole. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for IV Persantine is dipyridamole. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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IV Persantine products in the Orange Book

IV Persantine products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection5MG/MLDiscontinuedNone2AP

NDA 019817, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dipyridamole

Approved generic versions of IV Persantine
CompanyANDATE codeApprovedStrengths
HIKMA PHARMACEUTICALS USA INC074521AP (A-rated, therapeutically equivalent)October 18, 19965MG/ML
CHARTWELL INJECTABLES LLC074939AP (A-rated, therapeutically equivalent)April 13, 19985MG/ML

Questions

Is there a generic for IV Persantine?

Yes. The generic name for IV Persantine is dipyridamole. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for IV Persantine?

The active ingredient in IV Persantine is dipyridamole, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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